Policy 130.25 - Conducting Research Involving Human Subjects

This

Replaces

File:

130.25

130.25

Date:

10/22/01

03/02/00

ORIGINATOR: Provost and Chief Academic Officer

SUBJECT: Conducting Research Involving Human Subjects

Purpose

In accordance with USM Policy on Human Subjects of Research (IV - 2.10) and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Ethical Principles and Guidelines for the Protection of Human Subjects of Research (April 18, 1979)*, UMUC faculty, staff, and students who wish to conduct research involving human subjects must adhere to this Policy before conducting any research. Individuals external to UMUC who wish to conduct research involving UMUC faculty, staff, and/or students must also adhere to this Policy before conducting any research. The purpose of this Policy is:

to institute procedures that protect the rights and welfare of human subjects used in research, and

to establish clear guidelines that support the integrity of data collection.

Any inquiries regarding UMUC data collection and surveying should be directed to UMUC-Adelphi's Office of Institutional Accountability, Planning, and Research, Room 3105.

Definitions

An individual is considered to be at minimal risk if the risks of harm anticipated are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests, and that any information taken from the individual is recorded in such a manner that the individual cannot be identified.

An individual is considered to be at more than minimal risk if exposed to the possibility of harm—physical, psychological, social, legal, or other—in the proposed research which departs from the performance of routine physical or psychological examinations and tests, or which departs from established and accepted procedures necessary to meet the individual's needs, or which increases the probability or magnitude of risks ordinarily encountered in daily life.

Research involving human subjects can be classified into two groups, 1) research that involves minimal risk and 2) research that involves more than minimal risk:

Institutional Review Board (IRB)

IRB Membership - UMUC has established an Institutional Review Board (IRB) to review all applications for research involving human subjects. The IRB may approve, require modification as a condition of approval, or reject proposed research activities that are covered by this Policy. The IRB consists of nine members: the Provost who will serve as the Committee's Chair, the Vice President for Planning and Accountability, the Vice Provost, Academic Affairs, the Dean of Undergraduate Programs, the Dean of Graduate Programs, the Associate Dean, UMUC-Asia, the Associate Dean, UMUC-Europe, and two full-time, collegiate faculty members who are selected by UMUC's Faculty Advisory Council. The Provost, Deans, Vice Provost, and Vice President may each designate a representative to serve in their place. The UMUC-Adelphi Office of Institutional Accountability, Planning, and Research will assist the Chair by providing technical support and research review when requested.

The IRB will hold an annual meeting to review this Policy and the procedures for conducting research involving human subjects.

IRB Representatives - The Dean of Undergraduate Programs will serve as the IRB representative for all undergraduate students, faculty, and staff. The Dean of Graduate Programs will serve as the IRB representative for all graduate students, faculty, and staff. The Associate Dean, UMUC-Europe will serve as the IRB representative for all UMUC-Europe and Schwäbisch Gmünd students, faculty, and staff. The Associate Dean, UMUC-Asia, will serve as the IRB representative for all UMUC-Asia students, faculty, and staff. The Vice President for Planning and Accountability will serve as the IRB representative for all administrative office staff (such as Human Resources, Legal Affairs, Facilities, Finance, Government Relations, etc) of UMUC-Adelphi.

All researchers much complete the Research Project Notification and Human Subjects Protection Form (or the "research form") and receive proper approval prior to initiating research. The research form is on the UMUC web site and the UMUC Intranet web site.

UMUC Students - Students who wish to conduct research that involves human subjects in fulfillment of course requirements must complete the research form and submit it to their course instructor for approval. If the instructor determines that the research involves only the student's class and that there is minimal risk to the human subjects, the research activity may be approved. If the instructor determines that there may be a risk to human subjects or the research involves human subjects outside of the student's immediate class, the instructor will forward the application form to the appropriate unit IRB representative. The IRB representative may decide on behalf of the IRB that the human subjects are not exposed to more than minimal risk and may approve the proposed research activity. If the proposal involves more than minimal risk, the proposal will be brought to the IRB for a full review, as described in section V.

UMUC Students, Faculty, and Staff - UMUC students (conducting research not in fulfillment of course requirements), faculty, and staff who wish to conduct research involving human subjects must complete the research form and submit it to their IRB representative. The IRB representative may decide on behalf of the IRB that the human subjects are not exposed to more than minimal risk and may approve the proposed research activity. If the proposal involves more than minimal risk, the proposal will be brought to the IRB for a full review, as described in section V.

Individuals External to UMUC - Individuals external to UMUC who wish to conduct research involving UMUC faculty, staff, and/or students must complete the research form and submit the application to the IRB Chair or IRB Chair designee. All applications for individuals external to UMUC will be brought to the IRB for a full review, as described in section V.

All Categories - If the research proposed receives IRB approval, the proposer shall forward the approved and completed form to the appropriate research office, as described in Section VI, to verify quality control in UMUC research. Once all approval signatures are obtained on the research form, the proposer may undertake the research.

IRB Review

For proposals that are determined to be minimal risk and/or are required as part of regular state, federal, and USM data collection that maintains confidentiality, reviews may be completed by a single IRB representative, or in the case of UMUC students in Section IV.1., the course instructor. IRB reviews will be generally completed and returned to the proposer within seven (7) working days from receipt of the completed form.

For proposals that are determined to involve more than minimal risk and/or are from individuals external to UMUC, the IRB will convene a full review meeting consisting of at least five members by any mode of communication. Full review requires the completed research form to be circulated to all IRB members for review and comment. Issues of clarification and issues related to the adequacy of scientific design and appropriate controls may emerge during review. Full IRB reviews will be generally completed within ten (10) working days from receipt of the completed form.

Assuring Quality Control in UMUC Research Efforts to avoid excessive surveying of UMUC students, faculty, and staff, which could result in the degradation of response rates to state, federal, and USM mandated surveys, will be enforced worldwide by UMUC-Adelphi's Office of Institutional Accountability, Planning, and Research (Room 3105), UMUC-Asia's Office of Institutional Research, and UMUC-Europe's Office of Institutional Planning. Quality control reviews will be generally completed and returned to the proposer within seven (7) working days from receipt of the completed form. Please refer any inquiries regarding surveying to the appropriate office.

UMUC Data Library and Archives
Abstracts of all proposals will be kept for three years in the UMUC-Adelphi Office of Institutional Accountability, Planning, and Research (Room 3105). All completed research forms, electronic research files, proposals, research reports and data collection instruments must be stored in the UMUC-Adelphi Office of Institutional Accountability, Planning, and Research (Room 3105) for three years so that the data will be available to future UMUC researchers.

*A copy of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Ethical Principles and Guidelines for the Protection of Human Subjects of Research is available in the IRAHE office.